This pilot phase I trial studies fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) before surgery in mapping lymph nodes in patients with stage IB cervical cancer or endometrial cancer that grows and spreads quickly (high-grade). Lymph nodes are linked together by vessels called lymphatic channels and they also contribute to tumor spreading from one lymph node to another. 18F-FDG is a radioactive substance that is injected into the cervix and is taken up by cancer cells making them light up during PET/CT scan. 18F-FDG PET/CT may show more clearly which lymph nodes in the pelvis contain tumor cells and need to be removed during surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02285192.
PRIMARY OBJECTIVE:
I. To evaluate the diagnostic accuracy of intracervical 18F-FDG positron lymphography for sentinel lymph node (SLN) location compared with that of SLN mapping with conventional dye techniques in women undergoing surgery for stage IB1 cervical cancer or operative staging for clinical stage I high-grade endometrial cancer at Memorial Sloan Kettering Cancer Center (MSKCC).
SECONDARY OBJECTIVES:
I. To examine the diagnostic accuracy of intracervical 18F-FDG positron lymphography for tumor status of the SLN.
II. To evaluate several standardized uptake value (SUV) (18F-FDG avidity) thresholds (cutoffs) for categorizing suspicious nodes in positron lymphography that correlate with positive nodal status (i.e., malignant) on final pathology.
III. To estimate the biological half-life (t=1/2) of intracervical 18F-FDG.
IV. To report any short- and long-term adverse events.
V. To report any additional (termed “extra”) lymph nodes that are removed as a consequence of the positron lymphography protocol.
VI. To collect and report data on demographic characteristics, surgical procedures performed, and intraoperative characteristics.
OUTLINE:
Patients undergo 18F-FDG PET/CT lymphography. Patients then undergo surgery and lymph nodes are removed based on the positron lymphography.
After completion of study treatment, patients are followed up for 6 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJennifer Mueller
